SAINT® Neuromodulation System for the Treatment of Depression in an Inpatient Setting
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 8
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS) Remission Rates
研究概览
简要总结
Randomized, multi-site, sham-controlled, double-blinded study
详细描述
This multi-site, double-blind, randomized, sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System (MNS) with Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT) Technology for the treatment of depression and suicidal cognitions in psychiatrically hospitalized patients with Major Depressive Disorder (MDD) and active suicidal ideation (SI). This will be accomplished by applying the MNS with SAINT protocol (10 applications per day to a customized target within the left dorsolateral prefrontal cortex (L-DLPFC) identified with fMRI for five consecutive days) and measuring changes in depressive symptoms and suicidality at baseline and immediate-post visit.
Th clinical hypothesis is that participants receiving per-protocol active SAINT stimulation will demonstrate a significant difference in Montgomery-Asberg Depression Rating Scale (MADRS) scores/remission rates at the immediate post treatment visit, compared to those who receive per protocol sham SAINT stimulation.
The primary objective of this study is to determine the efficacy of active SAINT vs. sham SAINT in reducing symptoms of depression as measured by the MADRS.
The study will enroll approximately 100 participants and employ a two-arm design with 50 subjects per arm. The target population is adults of all genders and ethnicities who are between 18 and 75 years of age with a diagnosis of treatment-resistant MDD experiencing a current Major Depressive Episode, with active suicidal ideation, and who are otherwise in good general health. Participants must be without contraindications to Magnetic Resonance Imaging (MRI) or transcranial magnetic stimulation (TMS) and must be able to attend all study visits.
This study will deliver both active and sham SAINT via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 10 daily sessions (50 total over 5-days) of MNS with SAINT stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex). An operator entered code (derived from the study EDC) will instruct the device to deliver active or sham magnetic stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of all genders between the ages of 18 and 75 years at the time of screening, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode
- •Concurrently enrolled in the NIH multi-site trial titled "The Effects of SAINT® Neuromodulation System on Explicit and Implicit Suicidal Cognition"
- •Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires/follow instructions during fMRI assessments and SAINT treatments
- •Stated willingness to comply with all study procedures including availability for the duration of the study and to communicate with study personnel about adverse events and other clinically important information
- •Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a current Major Depressive Episode (MDE) according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5)
- •Medical records confirming a history of moderate to severe treatment- resistance as defined by a score of 7-14 on the Maudsley Staging Method153 (MSM)
- •Endorses clinically significant explicit suicidal cognitions (score ≥ 9 on the M-SSI and score ≥ 6 on the BSS self-report)
- •MADRS score of ≥20 at screening (visit 1)
- •rTMS/iTBS naive
- •Access to ongoing psychiatric care before and after completion of the study
- •Access to clinical rTMS after hospital discharge
- •In good general health, as evidenced by medical history
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. Must have a negative urine pregnancy test prior to enrollment
排除标准
- •Pregnancy as confirmed by a positive urine pregnancy test
- •The presence or diagnosis of a prominent anxiety disorder, personality disorder, or dysthymia which in the Investigator's opinion is predominant to MDD
- •Depressed mood/dysphoria as a result of an illness other than MDD (e.g. gender dysphoria)
- •Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
- •Current mania or psychosis
- •A history of Bipolar Affective Disorder or Primary Psychotic Disorder
- •Autism Spectrum disorder or Intellectual Disability
- •A diagnosis of obsessive-compulsive disorder (OCD)
- •Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
- •Urine screening test positive for illicit substances
- •Any history of ECT (greater than 8 sessions) without meeting responder criteria
- •Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT)
- •History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
- •Untreated or insufficiently treated endocrine disorder
- •Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
- •Contraindications to MRI (ferromagnetic metal in their body)
- •Any current or past history of any physical condition which, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
- •Treatment with another investigational drug or other intervention within the study period
- •Depth-adjusted SAINT® treatment dose > 65% maximum stimulator output (MSO)
- •Any other condition deemed by the PI to interfere with the study or increase risk to the participant
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS) Remission Rates
时间窗: Screening/Baseline, Immediate Post Visit
Ten item diagnostic questionnaire which psychiatrists use to measure the severity of depressive symptoms in patients with mood disorders. We will assess the difference in MADRS scores/remission rates between the per-protocol active SAINT group compared to those who received per-protocol sham treatment at the immediate post treatment visit.
次要结局
- Modified Scale for Suicidal Ideation (M-SSI)(Screening/Baseline, Immediate Post Visit)
- Montgomery-Asberg Depression Rating Scale (MADRS) Response Rates(Screening/Baseline, Immediate Post Visit)
- Columbia Suicide Severity Rating Scale (C-SSRS)(Screening/Baseline, Immediate Post Visit)